The Ultimate Resource for Pharmaceutical SOPs and Best Practices
1.0 Objective: To establish a procedure for labeling and identifying raw materials in the manufacturing process to ensure their traceability, proper storage, and product quality. 2.0 Scope: This standard operating procedure (SOP) applies to all raw materials used in manufacturing at the company premises. 3.0 Responsibilities: All personnel engaged in the labeling, movement, and storage…
Title: Raw Material Reconciliation Procedure Objective: To ensure that there is an accurate and regular reconciliation of raw materials available in the inventory, incoming materials, and materials used in production at all times. Scope: This SOP applies to all departments that handle raw materials, including those who: – Receive, inspect, and process incoming raw materials…
1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for cleaning and sanitizing raw materials used in the manufacturing process. 2. Scope: This SOP is applicable to all raw materials received and used in the manufacturing process. 3. Responsibilities: The Quality Control (QC) department is responsible for implementing the…
1.0 Purpose: The purpose of this SOP is to establish a standardized protocol for the retention of raw materials utilized in laboratory and manufacturing processes. This procedure is aimed to ensure the identification, traceability, and timely retrieval of these materials in the case of any need for testing, re-examination, or re-validation. 2.0 Scope: This procedure…
1. Purpose The purpose of this standard operating procedure (SOP) is to provide guidance on the raw material sampling plan procedure. This SOP outlines the process of sampling and testing raw materials to ensure they meet the required quality standards for use in the manufacturing process. 2. Scope This SOP applies to all staff involved…
1.0 Scope: This Standard Operating Procedure (SOP) is applicable to all personnel involved in the transportation of raw materials for the production process. 2.0 Purpose: The purpose of this SOP is to establish guidelines for the safe and efficient transportation of raw materials from the supplier to the production facility. 3.0 Responsibilities: 1. Production Manager…
1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to establish a Raw Material Specification Review Procedure to ensure that all raw materials received by our organization are within the defined specifications as per the supplier’s product data sheet and meet the intended use of our products. 2.0 Scope: This procedure applies to…
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1. Purpose The purpose of this Standard Operating Procedure (SOP) is to provide a guideline for the raw material stability testing procedure and its review. 2. Scope This SOP applies to all raw materials used in the production process. 3. Responsibilities The Quality Control (QC) department is responsible for conducting the raw material stability testing….
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1. Purpose: The purpose of this SOP is to outline the quarantine procedure for raw materials received at the facility and ensure that they are appropriately screened before entering the production process. 2. Scope: This procedure applies to all raw materials and packaging materials received at the facility. 3. Responsibilities: The Quality Control (QC) department…
1. Purpose: The purpose of this standard operating procedure (SOP) is to ensure that all raw material suppliers are qualified, evaluated and approved prior to their use in our company’s products. 2. Scope: This SOP applies to all raw materials used in our company’s products, including but not limited to active pharmaceutical ingredients (API), excipients,…
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